Concomitant cystocele repair and placement of a pubovaginal sling for the treatment of urinary incontinence by means of a transvaginal approach is known in the art. In this regard, a high correlation exists between such medical conditions and it is frequently desirable to address both via a single surgical procedure. Specifically, such procedure seeks to accomplish both goals of lifting and tightening the tissue around the bladder so that it no longer pushes against weakened tissue in the front wall of the vagina (i.e., cystocele) and positioning a sling beneath the urethra in order to provide structural support thereto such that accidental leakage of urine is eliminated or substantially reduced, particularly during provocative events such as coughing and the like.
The specifics regarding suburethral sling surgical procedures are described in detail in the references of Blaivas, Jerry G., Successful Pubovaginal Sling Surgery, Contemporary Urology, July, 1993; Blaivas, Jerry, G. Treatment of Female Incontinence Secondary To Urethral Damage Or Loss, Urologic Clinics of North America, Vol. 18, No. 2, May, 1991; Raz, Schlomo, Surgical Therapy For Urinary Incontinence, Atlas Of Transvaginal Surgery, W. B. Saunders, 1992, Loughlin, K. R., The Endoscopic Fascial Sling Treatment of Female Urinary Stress Incontinence, J. Urol, 1996, A.P.R.; 155 (4): 1265-7; and Staskin, D. R., et al., The Gore-Tex Sling Procedure For Female Sphincteric Incontinence: Indications, Technique And Results, J. Urol, 1997; 15(5): 295-9, the teachings of which are expressly incorporated herein by reference.
With respect to the simultaneous repair of the cystocele and placement of a pubovaginal sling, such procedure is disclosed by Kobashi et al., in the reference A New Technique for Cystocele Repair and Transvaginal Sling: the Cadaveric Prolapse Repair and Sling (CaPS), Urology, December, 2000 4:56 (Suppl. 1): 9-14 and by Chung et al., in the reference Technique of Combined Pubovaginal Sling and Cystocele Repair Using a Single Piece of Cadaveric Dermal Graft, Urology. 2002 April; 59(4): 538-41, the teachings of each of which are expressly incorporated herein by reference.
Despite the optimal opportunity to concurrently perform cystocele repair and pubovaginal sling surgery via a transvaginal approach, there has not to date been any type of implantable support material/tissue that is readily sized and configured to be surgically affixed into position such that both the bladder is properly supported (i.e., so that it no longer pushes against the vagina), and that the urethra is provided with a suburethral sling optimally positioned to treat the related condition of incontinence. In this respect, to the extent concurrent cystocele repair and pubovaginal sling surgery are performed, the prior art teaches the use of a harvested piece of tissue derived from a cadaver that must be surgically fashioned for implantation within a particular patient. To derive such implantable material, however, is exceptionally problematic due to the requirement that cadaveric tissue be available. Moreover, even to the extent a source of cadaveric tissue is available, the same must necessarily be excised to near precise dimensions and thereafter implanted with great care. In this respect, to the extent the harvested tissue is improperly sized or is otherwise torn or damaged during implantation, such supportive material will be rendered useless and require that at least one additional segment of material be harvested. As a consequence, substantial time, expense, and potential patient discomfort associated with such surgical procedure can frequently occur.
Accordingly, there is a substantial need in the art for a surgical implant operative to serve both as a suburethral sling for the treatment of incontinence, as well as provide structural support necessary to effectuate cystocele repair. There is additionally a need in the art for such an implant that can be readily fabricated from known implantable materials, and specifically sized and configured for immediate surgical implantation in procedures involving both the placement of a suburethral sling and supportive tissue to effectuate cystocele repair. There is still a further need in the art for such an implant that may be fabricated from materials possessing desirable properties, such as biocompatibility, material strength, and adaptability for use in surgical procedures. There is yet a further need in the art for such an implant that is of exceedingly simple construction, low cost to manufacture, and is capable of being readily deployed using known surgical techniques.